Product and Manufacturing Engineer
Resume:
Stephen Michael Ullom
Windsor CA• 626-***-****
*******.*****@*****.***
Manufacturing Engineer
• 8 years of manufacturing engineering experience developing/leading quality department
• Reduced in-house system production failure rate by 40%
• Well versed in the creation and implementation of Non-conformance Processes used to generate reports (weekly/monthly/quarterly) to reduce high impact issues
• Strong cross-department communication skills (Engineering/Marketing/Software/Service) used to develop more efficient testing methods, instructions, and improvement to the design of all product
• Managed Quality team of 7 while effectively performing tasks within executive management schedule
• Released and implemented multiple products, sub-assemblies, and parts using ECN process
Professional Experience
Inscopix, Palo Alto Ca. 2014-Present
Manufacturing/Product Engineer
• Created and implemented Non-conformance Process to aid the weekly/monthly/quarterly reporting of high impact issues
• Verified and dispositioned all Production/RMA process and material non-conformances
• Created all Production/RMA Travelers and Bill of Materials for system and assemblies
• Created all Receiving Inspection documentation for raw material (including lenses)
• Created all QII’s for system, assemblies, and consumables
• Helped to refine/create product specifications for product and consumables
• Helped to maintain production throughput daily; resolved critical issues affecting the floor
• Designed and created customer/internal product packaging for Top Assembly System and consumables (lenses)
• Helped to implement 5s standards on production floor and warehouse (proper bin storage, labeling, assignment of PN(s) to hardware/fixtures/tools, defining proper location for tools/fixtures/equipment)
• Designed and implemented multiple tools/fixtures for production using Solid Works
• Created/Released Drawings, MPI’s, QII’s, Travelers, BOM’s and Receiving Inspection Documentation for multiple products using ECN process
Performed low level functional tests/inspections on PCB Assemblies to ensure high sub-assembly throughput (pin-out/connectivity/software tests)
Varian Medical Systems, Palo Alto Ca. 2012 - 2014
Oncology Systems
Quality Engineer (promotion) 2014
• Owner and reviewer of CAPA’s ensuring proper timeline, plan, actions, and effectiveness of CAPA’s are compliant and result in the removal of issue identified through root cause analysis
• Owner and reviewer of Issue Reviews (RCAs) ensuring correctly documented investigation and risk assessments prior to escalation to CAPA
• DMR CAPA owner responsible for ensuring global DMRI-DMR process adheres to regulation requirements (procedure/work-instructions/template)
Manufacturing Engineer 2012-2014
• Revised Varian monthly/quarterly quality data review structure to improve data acquisition and refine focus for high impact issues
• Responsible for reducing production (Varian) caused impact time related to normal production build
• Restructured and created an implementation timeline for the improvement of production non-conformances, identification and segregation of non-conformances, and the rework for non-conforming material
• Redeveloped and restructured facility SAP nonconformance record for metric reporting (project reduced yearly cost by 300k and improved nonconformance closure cycle time by 50%)
• Instrumental in developing an CAPA escalation channel from the first instance/notification of issue (production and service), RCA of issue, Issue Review (part of team), to possible CAPA escalation
• Responsible for RCA of issues as well as possible closure through related CAPA process
• Process Validation Coordinator
Optovue Inc., Fremont Ca. 2008-2012
Ophthalmic Device Company
Manufacturing Engineer
• Created/modified/updated various assemblies and system manufacturing process instructions (tooling, assemblies, system calibration, system quality)
• Perform process validation for various issues on the production floor to help modify/improve design specifications within acceptable guidelines
• Complete and submit problem reports for ECR process (Windchill/Oracle/Excel)
• Provide company monthly and quarterly quality review data (including defect part numbers/quantity/reason/possible solutions)
• Responsible for Directly Communicating with all vendors regarding quality related issues to improve process and material
• Directly communicate with Repair-Service Department to resolve DOA systems and issues that could not otherwise be resolved by normal production process (performed RCCA)
• Perform incoming inspection on lenses and sheet metal components (verify/compare to engineering specifications)
• Manage quality team of 7(implement targets, goals, and daily schedule)
• Perform various transactions for components, systems, and assemblies in Oracle (WIP Issue/Move/Complete Transactions)
• Created weekly-monthly quarterly review reports using NCR stored data(Oracle/Excel) for both regulatory and engineering departments (included functional/cosmetic/manufacturing related issues)
• Improved process efficiency by notifying which defects parts are above specified limit and initiated appropriate corrective actions for items with issue (determine if material/design/vendor issue)
• Used various process validation techniques (retrospective/prospective) to help generate all Quality Insurance Instructions (QII) for both system lines (IPQC/FQC process)
• Initiated NCR (Oracle/Excel) process to include formal statements of issue/repair, symptom codes, correct defect part numbers, and signed of by the right personnel
• Represented Manufacturing/Quality in presenting appropriate documentation/information during TUV and FDA audits following Current Good Manufacturing Practice standards
• Develop testing protocol for PCBA Boards using company GUI software, prior to being released to production (reduced production failure rate from 20-30% to less than 1%)
Spectra-Physics(Newport Corp), Mountain View Ca. 2008-2008
Laser Production/Alignment
Laser Technician (Temporary Employee)
• Extensive knowledge in the design and application of various laser systems
• Hands on experience in the complete construction and alignment of lasers from start to finish, with the use of excel, power meters, photo-detectors, alignment mirrors, beam splitters, and an M-squared box
• Determination of symmetry, divergence, wavelength stability and curvature to successfully ship a laser under given specifications
• Responsible for the cleaning and if necessary the replacement of optics in laser when under construction
Education/Skills/Hobbies
University of California, Davis, Applied Science and Engineering, Davis, CA
Optical Science and Engineering, B.S., June 2008
Proficient in Solid Works, Oracle, Windchill, MS Office, Photoshop, Powerpoint, MS Excel, and familiar with Matlab, Lab View, Vector Works, C, Jira, Confluence, and C++
Contact this candidate